Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06936657 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Intervention Effects of Optimized Carbohydrate Diet in Patients With Type 2 Diabetes

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Dec 30, 2026 to Jun 30, 2027 Start date: Apr 20, 2025 to Oct 20, 2025 · Completion date: Mar 31, 2027 to Oct 31, 2027v3 Show 2 more changesShow less
    • Start date: Apr 20, 2025 to Oct 20, 2025
    • Completion date: Mar 31, 2027 to Oct 31, 2027
  2. Secondary endpoints: details revised at 1 of 14 entriesv2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study is a multi-center, randomized, crossover investigator-initiated trial conducted at Shanghai Sixth People's Hospital and other centers. Each participant will undergo two 12-week dietary intervention phases, separated by a 6-week washout, for a total study duration of 30 weeks. Participants will be randomly assigned in a 1:1 ratio to one of two intervention order: (1) optimized carbohydrate diet-washout-conventional diabetes diet, or (2) conventional diabetes diet-washout-optimized carbohydrate diet. The optimized carbohydrate diet is a modified diet with adjusted carbohydrate composition and proportions, while the conventional diabetes diet adheres to an energy-matched protocol in accordance with diabetes dietary guidelines. The study aims to explore the effects of the optimized carbohydrate diet on blood glucose control and glucose metabolism in patients with type 2 diabetes, and to systematically assess its impact on cognitive function and a range of physiological and psychological indicators (such as depression, anxiety, appetite, sleep, bowel habits and others).
Trial Details
NCT Number NCT06936657
Lead Sponsor Shanghai 6th People's Hospital
Conditions Type 2 Diabetes Mellitus (T2DM)
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov